Band stop filter employing a capacitor and an inductor tank circuit to enhance MRI compatibility of active implantable medical devices

ABSTRACT

A band stop filter is provided for a lead wire of an active implantable medical device (AIMD). The band stop filter includes a capacitor in parallel with an inductor. The parallel capacitor and inductor are placed in series with the implantable lead wire of the AIMD, wherein values of capacitance and inductance are selected such that the band stop filter is resonant at a selected frequency. The Q of the inductor may be relatively maximized and the Q of the capacitor may be relatively minimized to reduce the overall Q of the band stop filter to attenuate current flow through the implantable lead wire along a range of selected frequencies. In a preferred form, the band stop filter is integrated into a TIP and/or RING electrode for the active implantable medical device.

BACKGROUND OF THE INVENTION

This invention relates generally to novel EMI tank filter assemblies,particularly of the type used in active implantable medical devices(AIMDs) such as cardiac pacemakers, cardioverter defibrillators,neurostimulators, and the like, which decouple implantable lead wiresand/or electronic components of the implantable medical device fromundesirable electromagnetic interference (EMI) signals at a selectedfrequency or frequencies, such as the RF pulsed fields of MagneticResonance Imaging (MRI) equipment.

Compatibility of cardiac pacemakers, implantable defibrillators andother types of active implantable medical devices with magneticresonance imaging (MRI) and other types of hospital diagnostic equipmenthas become a major issue. If one goes to the websites of the majorcardiac pacemaker manufacturers in the United States, which include St.Jude Medical, Medtronic and Boston Scientific (formerly Guidant), onewill see that the use of MRI is generally contra-indicated withpacemakers and implantable defibrillators. See also:

-   (1) Safety Aspects of Cardiac Pacemakers in Magnetic Resonance    Imaging”, a dissertation submitted to the Swiss Federal Institute of    Technology Zurich presented by Roger Christoph Lüchinger, Zurich    2002;-   (2) “1. Dielectric Properties of Biological Tissues: Literature    Survey”, by C. Gabriel, S. Gabriel and E. Cortout;-   (3) “II. Dielectric Properties of Biological Tissues: Measurements    and the Frequency Range 0 Hz to 20 GHz”, by S. Gabriel, R. W. Lau    and C. Gabriel;-   (4) “III. Dielectric Properties of Biological Tissues: Parametric    Models for the Dielectric Spectrum of Tissues”, by S. Gabriel, R. W.    Lau and C. Gabriel; and-   (5) “Advanced Engineering Electromagnetics, C. A. Balanis, Wiley,    1989;-   (6) Systems and Methods for Magnetic-Resonance-Guided Interventional    Procedures, Patent Application Publication US 2003/0050557, Susil    and Halperin et. al, published Mar. 13, 2003;-   (7) Multifunctional Interventional Devices for MRI: A Combined    Electrophysiology/MRI Catheter, by, Robert C. Susil, Henry R.    Halperin, Christopher J. Yeung, Albert C. Lardo and Ergin Atalar,    MRI in Medicine, 2002; and-   (8) Multifunctional Interventional Devices for Use in MRI, U.S.    Patent Application Ser. No. 60/283,725, filed Apr. 13, 2001.

The contents of the foregoing are all incorporated herein by reference.

However, an extensive review of the literature indicates that MRI isindeed often used with pacemaker, neurostimulator and other activeimplantable medical device (AIMD) patients. The safety and feasibilityof MRI in patients with cardiac pacemakers is an issue of gainingsignificance. The effects of MRI on patients' pacemaker systems haveonly been analyzed retrospectively in some case reports. There are anumber of papers that indicate that MRI on new generation pacemakers canbe conducted up to 0.5 Tesla (T). MRI is one of medicine's most valuablediagnostic tools. MRI is, of course, extensively used for imaging, butis also used for interventional medicine (surgery). In addition, MRI isused in real time to guide ablation catheters, neurostimulator tips,deep brain probes and the like. An absolute contra-indication forpacemaker patients means that pacemaker and ICD wearers are excludedfrom MRI. This is particularly true of scans of the thorax and abdominalareas. Because of MRI's incredible value as a diagnostic tool forimaging organs and other body tissues, many physicians simply take therisk and go ahead and perform MRI on a pacemaker patient. The literatureindicates a number of precautions that physicians should take in thiscase, including limiting the power of the MRI RF Pulsed field (SpecificAbsorption Rate—SAR level), programming the pacemaker to fixed orasynchronous pacing mode, and then careful reprogramming and evaluationof the pacemaker and patient after the procedure is complete. There havebeen reports of latent problems with cardiac pacemakers or other AIMDsafter an MRI procedure sometimes occurring many days later. Moreover,there are a number of recent papers that indicate that the SAR level isnot entirely predictive of the heating that would be found in implantedlead wires or devices. For example, for magnetic resonance imagingdevices operating at the same magnetic field strength and also at thesame SAR level, considerable variations have been found relative toheating of implanted lead wires. It is speculated that SAR level aloneis not a good predictor of whether or not an implanted device or itsassociated lead wire system will overheat.

There are three types of electromagnetic fields used in an MRI unit. Thefirst type is the main static magnetic field designated B₀ which is usedto align protons in body tissue. The field strength varies from 0.5 to3.0 Tesla in most of the currently available MRI units in clinical use.Some of the newer MRI system fields can go as high as 4 to 5 Tesla. Atthe recent International Society for Magnetic Resonance in Medicine(ISMRM), which was held on 5 and 6 Nov. 2005, it was reported thatcertain research systems are going up as high as 11.7 Tesla and will beready sometime in 2006. This is over 100,000 times the magnetic fieldstrength of the earth. A static magnetic field can induce powerfulmechanical forces and torque on any magnetic materials implanted withinthe patient. This would include certain components within the cardiacpacemaker itself and or lead wire systems. It is not likely (other thansudden system shut down) that the static MRI magnetic field can inducecurrents into the pacemaker lead wire system and hence into thepacemaker itself. It is a basic principle of physics that a magneticfield must either be time-varying as it cuts across the conductor, orthe conductor itself must move within the magnetic field for currents tobe induced.

The second type of field produced by magnetic resonance imaging is thepulsed RF field which is generated by the body coil or head coil. Thisis used to change the energy state of the protons and illicit MRIsignals from tissue. The RF field is homogeneous in the central regionand has two main components: (1) the magnetic field is circularlypolarized in the actual plane; and (2) the electric field is related tothe magnetic field by Maxwell's equations. In general, the RF field isswitched on and off during measurements and usually has a frequency of21 MHz to 64 MHz to 128 MHz depending upon the static magnetic fieldstrength. The frequency of the RF pulse varies with the field strengthof the main static field where: RF PULSED FREQUENCY in MHz=(42.56)(STATIC FIELD STRENGTH IN TESLA).

The third type of electromagnetic field is the time-varying magneticgradient fields designated B₁ which are used for spatial localization.These change their strength along different orientations and operatingfrequencies on the order of 1 kHz. The vectors of the magnetic fieldgradients in the X, Y and Z directions are produced by three sets oforthogonally positioned coils and are switched on only during themeasurements. In some cases, the gradient field has been shown toelevate natural heart rhythms (heart beat). This is not completelyunderstood, but it is a repeatable phenomenon. The gradient field is notconsidered by many researchers to create any other adverse effects.

It is instructive to note how voltages and EMI are induced into animplanted lead wire system. At very low frequency (VLF), voltages areinduced at the input to the cardiac pacemaker as currents circulatethroughout the patient's body and create voltage drops. Because of thevector displacement between the pacemaker housing and, for example, theTIP electrode, voltage drop across the resistance of body tissues may besensed due to Ohms Law and the circulating current of the RF signal. Athigher frequencies, the implanted lead wire systems actually act asantennas where currents are induced along their length. These antennasare not very efficient due to the damping effects of body tissue;however, this can often be offset by extremely high power fields (suchas MRI pulsed fields) and/or body resonances. At very high frequencies(such as cellular telephone frequencies), EMI signals are induced onlyinto the first area of the lead wire system (for example, at the headerblock of a cardiac pacemaker). This has to do with the wavelength of thesignals involved and where they couple efficiently into the system.

Magnetic field coupling into an implanted lead wire system is based onloop areas. For example, in a cardiac pacemaker, there is a loop formedby the lead wire as it comes from the cardiac pacemaker housing to itsdistal TIP, for example, located in the right ventricle. The return pathis through body fluid and tissue generally straight from the TIPelectrode in the right ventricle back up to the pacemaker case orhousing. This forms an enclosed area which can be measured from patientX-rays in square centimeters. The average loop area is 200 to 225 squarecentimeters. This is an average and is subject to great statisticalvariation. For example, in a large adult patient with an abdominalimplant, the implanted loop area is much larger (greater than 450 squarecentimeters).

Relating now to the specific case of MRI, the magnetic gradient fieldswould be induced through enclosed loop areas. However, the pulsed RFfields, which are generated by the body coil, would be primarily inducedinto the lead wire system by antenna action.

There are a number of potential problems with MRI, including:

-   -   (1) Closure of the pacemaker reed switch. A pacemaker reed        switch, which can also be a Hall Effect device, is designed to        detect a permanent magnet held close to the patient's chest.        This magnet placement allows a physician or even the patient to        put the implantable medical device into what is known as the        “magnet mode response.” The “magnet mode response” varies from        one manufacturer to another, however, in general, this puts the        pacemaker into a fixed rate or asynchronous pacing mode. This is        normally done for short times and is very useful for diagnostic        and clinical purposes. However, in some cases, when a pacemaker        is brought into the bore or close to the MRI scanner, the MRI        static field can make the pacemaker's internal reed switch        close, which puts the pacemaker into a fixed rate or        asynchronous pacing mode. Worse yet, the reed switch may bounce        or oscillate. Asynchronous pacing may compete with the patient's        underlying cardiac rhythm. This is one reason why patients have        generally been advised not to undergo MRI. Fixed rate or        asynchronous pacing for most patients is not an issue. However,        in patients with unstable conditions, such as myocardial        ischemia, there is a substantial risk for ventricular        fibrillation during asynchronous pacing. In most modern        pacemakers the magnetic reed switch (or Hall Effect device)        function is programmable. If the magnetic reed switch response        is switched off, then synchronous pacing is still possible even        in strong magnetic fields. The possibility to open and re-close        the reed switch in the main magnetic field by the gradient field        cannot be excluded. However, it is generally felt that the reed        switch will remain closed due to the powerful static magnetic        field. It is theoretically possible for certain reed switch        orientations at the gradient field to be capable of repeatedly        closing and re-opening the reed switch.    -   (2) Reed switch damage. Direct damage to the reed switch is        theoretically possible, but has not been reported in any of the        known literature. In an article written by Roger Christoph        Lüchinger of Zurich, he reports on testing in which reed        switches were exposed to the static magnetic field of MRI        equipment. After extended exposure to these static magnetic        fields, the reed switches functioned normally at close to the        same field strength as before the test.    -   (3) Pacemaker displacement. Some parts of pacemakers, such as        the batteries and reed switch, contain ferrous magnetic        materials and are thus subject to mechanical forces during MRI.        Pacemaker displacement may occur in response to magnetic force        or magnetic torque. There are several recent reports on modern        pacemakers and ICDs that force and torque are not of concern for        MRI systems up to 3 Tesla.    -   (4) Radio frequency field. At the frequencies of interest in        MRI, RF energy can be absorbed and converted to heat. The power        deposited by RF pulses during MRI is complex and is dependent        upon the power (Specific Absorption Rate (SAR) Level) and        duration of the RF pulse, the transmitted frequency, the number        of RF pulses applied per unit time, and the type of        configuration of the RF transmitter coil used. The amount of        heating also depends upon the volume of tissue imaged, the        electrical resistivity of tissue and the configuration of the        anatomical region imaged. There are also a number of other        variables that depend on the placement in the human body of the        AIMD and its associated lead wire(s). For example, it will make        a difference how much current is induced into a pacemaker lead        wire system as to whether it is a left or right pectoral        implant. In addition, the routing of the lead and the lead        length are also very critical as to the amount of induced        current and heating that would occur. Also, distal TIP design is        very important as the distal TIP itself can act as its own        antenna wherein eddy currents can create heating. The cause of        heating in an MRI environment is two fold: (a) RF field coupling        to the lead can occur which induces significant local heating;        and (b) currents induced between the distal TIP and tissue        during MRI RF pulse transmission sequences can cause local Ohms        Law heating in tissue next to the distal TIP electrode of the        implanted lead. The RF field of an MRI scanner can produce        enough energy to induce lead wire currents sufficient to destroy        some of the adjacent myocardial tissue. Tissue ablation has also        been observed. The effects of this heating are not readily        detectable by monitoring during the MRI. Indications that        heating has occurred would include an increase in pacing        threshold, venous ablation, Larynx or e ablation, myocardial        perforation and lead penetration, or even arrhythmias caused by        scar tissue. Such long term heating effects of MRI have not been        well studied yet for all types of AIMD lead wire geometries.        There can also be localized heating problems associated with        various types of electrodes in addition to TIP electrodes. This        includes RING electrodes or PAD electrodes. RING electrodes are        commonly used with a wide variety of implanted devices including        cardiac pacemakers, and neurostimulators, and the like. PAD        electrodes are very common in neurostimulator applications. For        example, spinal cord stimulators or deep brain stimulators can        include a plurality of PAD electrodes to make contact with nerve        tissue. A good example of this also occurs in a cochlear        implant. In a typical cochlear implant there would be sixteen        RING electrodes that the position places by pushing the        electrode up into the cochlea. Several of these RING electrodes        make contact with auditory nerves.    -   (5) Alterations of pacing rate due to the applied radio        frequency field. It has been observed that the RF field may        induce undesirable fast pacing (QRS complex) rates. There are        various mechanisms which have been proposed to explain rapid        pacing: direct tissue stimulation, interference with pacemaker        electronics or pacemaker reprogramming (or reset). In all of        these cases, it is very desirable to raise the lead system        impedance (at the MRI RF pulsed frequency) to make an EMI filter        feedthrough capacitor more effective and thereby provide a        higher degree of protection to AIMD electronics. This will make        alterations in pacemaker pacing rate and/or pacemaker        reprogramming much more unlikely.    -   (6) Time-varying magnetic gradient fields. The contribution of        the time-varying gradient to the total strength of the MRI        magnetic field is negligible, however, pacemaker systems could        be affected because these fields are rapidly applied and        removed. The time rate of change of the magnetic field is        directly related to how much electromagnetic force and hence        current can be induced into a lead wire system. Lüchinger        reports that even using today's gradient systems with a        time-varying field up to 50 Tesla per second, the induced        currents are likely to stay below the biological thresholds for        cardiac fibrillation. A theoretical upper limit for the induced        voltage by the time-varying magnetic gradient field is 20 volts.        Such a voltage during more than 0.1 milliseconds could be enough        energy to directly pace the heart.    -   (7) Heating. Currents induced by time-varying magnetic gradient        fields may lead to local heating. Researchers feel that the        calculated heating effect of the gradient field is much less as        compared to that caused by the RF field and therefore for the        purposes herein may be neglected.

There are additional problems possible with implantable cardioverterdefibrillators (ICDs). ICDs use different and larger batteries whichcould cause higher magnetic forces. The programmable sensitivity in ICDsis normally much higher (more sensitive) than it is for pacemakers,therefore, ICDs may falsely detect a ventricular tacchyarrhythmia andinappropriately deliver therapy. In this case, therapy might includeanti-tacchycardia pacing, cardio version or defibrillation (high voltageshock) therapies. MRI magnetic fields may prevent detection of adangerous ventricular arrhythmia or fibrillation. There can also beheating problems of ICD leads which are expected to be comparable tothose of pacemaker leads. Ablation of vascular walls is another concern.Fortunately, ICDs have a sort of built-in fail-safe mechanism. That is,during an MRI procedure, if they inadvertently sense the MRI fields as adangerous ventricular arrhythmia, the ICD will attempt to charge up anddeliver a high voltage shock. However, there is a transformer containedwithin the ICD that is necessary to function in order to charge up thehigh-energy storage capacitor contained within the ICD. In the presenceof the main static field of the MRI the core of this transformer tendsto saturate thereby preventing the high voltage capacitor from chargingup. This makes it highly unlikely that an ICD patient undergoing an MRIwould receive an inappropriate high voltage shock therapy. While ICDscannot charge during MRI due to the saturation of their ferro-magnetictransformers, the battery will be effectively shorted and lose life.This is a highly undesirable condition.

In summary, there are a number of studies that have shown that MRIpatients with active implantable medical devices, such as cardiacpacemakers, can be at risk for potential hazardous effects. However,there are a number of reports in the literature that MRI can be safe forimaging of pacemaker patients when a number of precautions are taken(only when an MRI is thought to be an absolute diagnostic necessity).While these anecdotal reports are of interest, however, they arecertainly not scientifically convincing that all MRI can be safe. Aspreviously mentioned, just variations in the pacemaker lead wire lengthcan significantly effect how much heat is generated. From the layman'spoint of view, this can be easily explained by observing the typicallength of the antenna on a cellular telephone compared to the verticalrod antenna more common on older automobiles. The relatively shortantenna on the cell phone is designed to efficiently couple with thevery high frequency wavelengths (approximately 950 MHz) of cellulartelephone signals. In a typical AM and FM radio in an automobile, thesewavelength signals would not efficiently couple to the relatively shortantenna of a cell phone. This is why the antenna on the automobile isrelatively longer. An analogous situation exists with an AIMD patient inan MRI system. If one assumes, for example, a 3.0 Tesla MRI system,which would have an RF pulsed frequency of 128 MHz, there are certainimplanted lead lengths that would couple efficiently as fractions of the128 MHz wavelength. It is typical that a hospital will maintain aninventory of various leads and that the implanting physician will make aselection depending on the size of the patient, implant location andother factors. Accordingly, the implanted or effective lead wire lengthcan vary considerably. There are certain implanted lead wire lengthsthat just do not couple efficiently with the MRI frequency and there areothers that would couple very efficiently and thereby produce the worstcase for heating.

The effect of an MRI system on the function of pacemakers, ICDs andneurostimulators depends on various factors, including the strength ofthe static magnetic field, the pulse sequence (gradient and RF fieldused), the anatomic region being imaged, and many other factors. Furthercomplicating this is the fact that each patient's condition andphysiology is different and each manufacturer's pacemaker and ICDdesigns also are designed and behave differently. Most experts stillconclude that MRI for the pacemaker patient should not be consideredsafe. Paradoxically, this also does not mean that the patient should notreceive MRI. The physician must make an evaluation given the pacemakerpatient's condition and weigh the potential risks of MRI against thebenefits of this powerful diagnostic tool. As MRI technology progresses,including higher field gradient changes over time applied to thinnertissue slices at more rapid imagery, the situation will continue toevolve and become more complex. An example of this paradox is apacemaker patient who is suspected to have a cancer of the lung. RFablation treatment of such a tumor may require stereotactic imaging onlymade possible through real time fine focus MRI. With the patient's lifeliterally at risk, the physician with patient informed consent may makethe decision to perform MRI in spite of all of the previously describedattendant risks to the pacemaker system.

Insulin drug pump systems do not seem to be of a major current concerndue to the fact that they have no significant antenna components (suchas implanted lead wires). However, some implantable pumps work onmagneto-peristaltic systems, and must be deactivated prior to MRI. Thereare newer (unreleased) systems that would be based on solenoid systemswhich will have similar problems.

It is clear that MRI will continue to be used in patients with activeimplantable medical devices. Accordingly, there is a need for AIMDsystem and/or circuit protection devices which will improve the immunityof active implantable medical device systems to diagnostic proceduressuch as MRI.

As one can see, many of the undesirable effects in an implanted leadwire system from MRI and other medical diagnostic procedures are relatedto undesirable induced currents in the lead wire system and/or itsdistal TIP (or RING). This can lead to overheating either in the leadwire or at the body tissue at the distal TIP. For a pacemakerapplication, these currents can also directly stimulate the heart intosometimes dangerous arrhythmias.

Accordingly, there is a need for a novel resonant tank or band stopfilter assembly which can be placed at various locations along theactive implantable medical device lead wire system, which also preventscurrent from circulating at selected frequencies of the medicaltherapeutic device. Preferably, such novel tank filters would bedesigned to resonate at 64 MHz for use in an MRI system operating at 1.5Tesla (or 128 MHz for a 3 Tesla system). The present invention fulfillsthese needs and provides other related advantages.

SUMMARY OF THE INVENTION

The present invention comprises resonant tank circuits/band stop filtersto be placed at one or more locations along the active implantablemedical device (AIMD) lead wire system, including its distal Tip. Theseband stop filters prevent current from circulating at selectedfrequencies of the medical therapeutic device. For example, for an MRIsystem operating at 1.5 Tesla, the pulse RF frequency is 64 MHz. Thenovel band stop filters of the present invention can be designed toresonate at 64 MHz and thus create an open circuit in the implanted leadwire system at that selected frequency. For example, the band stopfilter of the present invention, when placed at the distal TIP, willprevent currents from flowing through the distal TIP, prevent currentsfrom flowing in the implanted lead wires and also prevent currents fromflowing into body tissue. It will be obvious to those skilled in the artthat all of the embodiments described herein are equally applicable to awide range of other active implantable medical devices, including deepbrain stimulators, spinal cord stimulators, cochlear implants,ventricular assist devices, artificial hearts, drug pumps, and the like.The present invention fulfills all of the needs regarding reduction orelimination of undesirable currents and associated heating in implantedlead wire systems.

Electrically engineering a capacitor in parallel with an inductor isknown as a tank filter. It is also well known that when the tank filteris at its resonant frequency, it will present a very high impedance.This is a basic principle of all radio receivers. In fact, multiple tankfilters are often used to improve the selectivity of a radio receiver.One can adjust the resonant frequency of the tank circuit by eitheradjusting the capacitor value or the inductor value or both. Sincemedical diagnostic equipment which is capable of producing very largefields operates at discrete frequencies, this is an ideal situation fora specific tank or band stop filter. Band stop filters are moreefficient for eliminating one single frequency than broadband filters.Because the band stop filter is targeted at this one frequency or rangeof frequencies, it can be much smaller and volumetrically efficientsuitable for incorporation into an implantable medical device. Inaddition, the way MRI RF pulse fields couple with lead wire systems,various loops and associated loop currents result along various sectionsof the implanted lead wire. For example, at the distal TIP of a cardiacpacemaker, direct electromagnetic forces (EMF) can be produced whichresult in current loops through the distal TIP and into the associatedmyocardial tissue. This current system is largely decoupled from thecurrents that are induced near the active implantable medical device,for example, near the cardiac pacemaker. There the MRI may set up aseparate loop with its associated currents. Accordingly, one or moreband stop filters may be required to completely control all of thevarious induced EMI and associated currents in a lead wire system.

The present invention which resides in band stop filters is alsodesigned to work in concert with the EMI filter which is typically usedat the point of lead wire ingress and egress of the active implantablemedical device. For example, see U.S. Pat. Nos. 5,333,095, entitledFEEDTHROUGH FILTER CAPACITOR ASSEMBLY FOR HUMAN IMPLANT; U.S. Pat. No.6,999,818, entitled INDUCTOR CAPACITOR EMI FILTER FOR HUMAN IMPLANTAPPLICATIONS; U.S. patent application Ser. No. 11/097,999 filed Mar. 31,2005, entitled APPARATUS AND PROCESS FOR REDUCING THE SUSCEPTIBILITY OFACTIVE IMPLANTABLE MEDICAL DEVICES TO MEDICAL PROCEDURES SUCH ASMAGNETIC RESONANCE IMAGING; and U.S. patent application Ser. No.11/163,915 filed Nov. 3, 2005, entitled PROCESS FOR TUNING AN EMI FILTERTO REDUCE THE AMOUNT OF HEAT GENERATED IN IMPLANTED LEAD WIRES DURINGMEDICAL PROCEDURES SUCH AS MAGNETIC RESONANCE IMAGING; the contents ofall being incorporated herein by reference. All of these patentdocuments describe novel inductor capacitor combinations for low passEMI filter circuits. It is of particular interest that by increasing thenumber of circuit elements, one can reduce the overall capacitance valuewhich is at the input to the implantable medical device. It is importantto reduce the capacitance value to raise the input impedance of theactive implantable medical device such that this also reduces the amountof current that would flow in lead wire systems associated with medicalprocedures such as MRI. Accordingly, it is a feature of the presentinvention that the novel band stop filters are designed to be used inconcert with the structures described in the above mentioned threepatent applications.

In one embodiment, the invention provides a medical therapeutic devicecomprising an active implantable medical device (AIMD), an implantablelead wire extending from the AIMD to a distal TIP thereof, and a bandstop filter associated with the implantable lead wire for attenuatingcurrent flow through the lead wire at a selected frequency.

The AIMD may comprise cochlear implants, piezoelectric sound bridgetransducers, neurostimulators, brain stimulators, cardiac pacemakers,ventricular assist devices, artificial hearts, drug pumps, bone growthstimulators, bone fusion stimulators, urinary incontinence devices, painrelief spinal cord stimulators, anti-tremor stimulators, gastricstimulators, implantable cardioverter defibrillators, pH probes,congestive heart failure devices, neuromodulators, cardiovascularstents, orthopedic implants, and the like.

The band stop filter itself comprises a capacitor (and its resistance oran added resistance) in parallel with an inductor (and its parasiticresistance), said parallel capacitor and inductor combination beingplaced in series with the medical device implantable lead wire(s)wherein the values of capacitance and inductance have been selected suchthat the band stop filter is resonant at a selected frequency (such asthe MRI pulsed frequency).

In the preferred embodiment, the overall Q factor of the band stopfilter is selected to balance impedance at the selected frequency versusfrequency band width characteristics. More specifically, the Q of theinductor is relatively maximized and the Q of the capacitor isrelatively minimized to reduce the overall Q of the band stop filter.The Q of the inductor is relatively maximized by minimizing theparasitic resistive loss in the inductor, and the Q of the capacitor isrelatively minimized by raising its equivalent series resistance (ESR)of the capacitor (or by adding resistance or a resistive element inseries with the capacitor element of the bank stop tank filter). Thisreduces the overall Q of the band stop filter in order to broaden its 3dB points and thereby attenuate current flow through the lead wire alonga range of selected frequencies. In AIMD or external medical deviceapplications, the range of selected frequencies includes a plurality ofMRI pulsed frequencies.

The equivalent series resistance of the capacitor is raised by any ofthe following: reducing thickness of electrode plates in the capacitor;using higher resistivity capacitor electrode materials, providingapertures, gaps, slits or spokes in the electrode plates of thecapacitor; providing separate discrete resistors in series with thecapacitor; utilizing resistive electrical attachment materials to thecapacitor; or utilizing capacitor dielectric materials that have highdielectric loss tangents at the selected frequency. Methods of usinghigher resistivity capacitor electrode materials include, for example,using platinum instead of silver electrodes. Platinum has a highervolume resistivity as compared to pure silver. Another way of reducingcapacitor electrode plate resistivity is to add ceramic powders to theelectrode ink before it is silk screened down and fired. After firing,this has the effect of separating the conductive electrode portions byinsulative dielectric areas which increases the overall resistivity ofthe electrode plate.

As defined herein, raising the capacitor ESR includes any or all of theabove described methods of adding resistance in series with thecapacitive element of the band stop filter. It should be noted thatdeliberately raising the capacitor ESR runs counter toconventional/prior art capacitor technologies. In fact, capacitormanufacturers generally strive to build capacitors with as low an ESR aspossible. This is to minimize energy loss, etc. It is a feature of thepresent invention that capacitor Q is raised in a controlled manner inthe tank filter circuit in order to adjust its Q and adjust the bandstop frequency width in the range of MRI pulsed frequencies.

Preferably, the band stop filter is disposed adjacent to the distal tipof the lead wire and is integrated into a TIP electrode. It may also beintegrated into one or more RING electrodes.

The present invention also provides a novel process for attenuatingcurrent flow through an implantable lead wire for an active implantablemedical device at a selected frequency, comprising the steps of:selecting a capacitor which is resonant at the selected frequency;selecting an inductor which is resonant at the selected frequency; usingthe capacitor and the inductor to form a tank filter circuit; andplacing the tank filter circuit in series with the lead wire.

The overall Q of the tank filter circuit may be reduced by increasingthe Q of the inductor and reducing the Q of the capacitor. In thisregard, minimizing resistive loss in the inductor maximizes the Q of theinductor, and raising the equivalent series resistance of the capacitorminimizes the Q of the capacitor.

The net effect is to reduce the overall Q of the tank filter circuitwhich widens the band stop width to attenuate current flow through thelead wire along a range of selected frequencies. As discussed herein,the range of selected frequencies may include a plurality of MRI pulsefrequencies.

Other features and advantages of the present invention will becomeapparent from the following more detailed description, taken inconjunction with the accompanying drawings which illustrate, by way ofexample, the principles of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings illustrate the invention. In such drawings:

FIG. 1 is a wire-formed diagram of a generic human body showing a numberof active implantable medical devices (AIMDs);

FIG. 2 is a perspective and somewhat schematic view of a prior artactive implantable medical device (AIMD) including a lead wire directedto the heart of a patient;

FIG. 3 is an enlarged sectional view taken generally along the line 3-3of FIG. 2;

FIG. 4 is a view taken generally along the line 4-4 of FIG. 3;

FIG. 5 is a perspective/isometric view of a prior art rectangularquadpolar feedthrough capacitor of the type shown in FIGS. 3 and 4;

FIG. 6 is sectional view taken generally along the line 6-6 of FIG. 5;

FIG. 7 is a sectional view taken generally along the line 7-7 of FIG. 5.

FIG. 8 is a diagram of a unipolar active implantable medical device;

FIG. 9 is a diagram similar to FIG. 8, illustrating a bipolar AIMDsystem;

FIG. 10 is a diagram similar to FIGS. 8 and 9, illustrating a biopolarlead wire system with a distal TIP and RING, typically used in a cardiacpacemaker;

FIG. 11 is a schematic diagram showing a parallel combination of aninductor L and a capacitor C placed in series with the lead wire systemsof FIGS. 8-10;

FIG. 12 is a chart illustrating calculation of frequency of resonancefor the parallel tank circuit of FIG. 11;

FIG. 13 is a graph showing impedance versus frequency for the paralleltank band stop circuit of FIG. 11;

FIG. 14 is an equation for the impedance of an inductor in parallel witha capacitor;

FIG. 15 is a chart illustrating reactance equations for the inductor andthe capacitor of the parallel tank circuit of FIG. 11;

FIG. 16 is a schematic diagram illustrating the parallel tank circuit ofFIG. 11, except in this case the inductor and the capacitor have seriesresistive losses;

FIG. 17 is a diagram similar to FIG. 8, illustrating the tankcircuit/band stop filter added near a distal electrode;

FIG. 18 is a schematic representation of the novel band stop tank filterof the present invention, using switches to illustrate its function atvarious frequencies;

FIG. 19 is a schematic diagram similar to FIG. 18, illustrating the lowfrequency model of the band stop filter;

FIG. 20 is a schematic diagram similar to FIGS. 18 and 19, illustratingthe model of the band stop filter of the present invention at itsresonant frequency;

FIG. 21 is a schematic diagram similar to FIGS. 18-20, illustrating amodel of the band stop filter at high frequencies well above theresonant frequency;

FIG. 22 is a decision tree block diagram illustrating a process fordesigning the band stop filters of the present invention;

FIG. 23 is graph of insertion loss versus frequency for band stopfilters having high Q inductors and differing quality “Q” factors;

FIG. 24 is a tracing of an exemplary patient x-ray showing an implantedpacemaker and cardioverter defibrillator and corresponding lead wiresystem;

FIG. 25 is a line drawings of an exemplary patent cardiac x-ray of abi-ventricular lead wire system;

FIG. 26 illustrates a bipolar cardiac pacemaker lead wire showing thedistal TIP and the distal RING electrodes; and

FIG. 27 is an enlarged, fragmented schematic illustration of the areaillustrated by the line 27-27 in FIG. 26.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 illustrates of various types of active implantable medicaldevices 100 that are currently in use. FIG. 1 is a wire formed diagramof a generic human body showing a number of implanted medical devices.100A is a family of implantable hearing devices which can include thegroup of cochlear implants, piezoelectric sound bridge transducers andthe like. 100B includes an entire variety of neurostimulators and brainstimulators. Neurostimulators are used to stimulate the Vagus nerve, forexample, to treat epilepsy, obesity and depression. Brain stimulatorsare similar to a pacemaker-like device and include electrodes implanteddeep into the brain for sensing the onset of the seizure and alsoproviding electrical stimulation to brain tissue to prevent the seizurefrom actually happening. 100C shows a cardiac pacemaker which iswell-known in the art. 100D includes the family of left ventricularassist devices (LVAD's), and artificial hearts, including the recentlyintroduced artificial heart known as the Abiocor. 100E includes anentire family of drug pumps which can be used for dispensing of insulin,chemotherapy drugs, pain medications and the like. Insulin pumps areevolving from passive devices to ones that have sensors and closed loopsystems. That is, real time monitoring of blood sugar levels will occur.These devices tend to be more sensitive to EMI than passive pumps thathave no sense circuitry or externally implanted lead wires. 100Fincludes a variety of implantable bone growth stimulators for rapidhealing of fractures. 100G includes urinary incontinence devices. 100Hincludes the family of pain relief spinal cord stimulators andanti-tremor stimulators. 100H also includes an entire family of othertypes of neurostimulators used to block pain. 100I includes a family ofimplantable cardioverter defibrillators (ICD) devices and also includesthe family of congestive heart failure devices (CHF). This is also knownin the art as cardio resynchronization therapy devices, otherwise knowsas CRT devices.

Referring now to FIG. 2, a prior art active implantable medical device(AIMD) 100 is illustrated. In general, the AIMD 100 could, for example,be a cardiac pacemaker 100C which is enclosed by a titanium housing 102as indicated. The titanium housing is hermetically sealed, however thereis a point where lead wires 104 must ingress and egress the hermeticseal. This is accomplished by providing a hermetic terminal assembly106. Hermetic terminal assemblies are well known and generally consistof a ferrule 108 which is laser welded to the titanium housing 102 ofthe AIMD 100. The hermetic terminal assembly 106 with its associated EMIfilter is better shown in FIG. 3. Referring once again to FIG. 2, fourlead wires are shown consisting of lead wire pair 104 a and 104 b andlead wire pair 104 c and 104 d. This is typical of what's known as adual chamber bipolar cardiac pacemaker.

The ISI connectors 110 that are designed to plug into the header block112 are low voltage (pacemaker) connectors covered by an ANSI/AAMIstandard IS-1. Higher voltage devices, such as implantable cardioverterdefibrillators, are covered by a standard known as the ANSI/AAMI DF-1.There is a new standard under development which will integrate both highvoltage and low voltage connectors into a new miniature connector seriesknown as the IS-4 series. These connectors are typically routed in apacemaker application down into the right ventricle and right atrium ofthe heart 114. There are also new generation devices that have beenintroduced to the market that couple lead wires to the outside of theleft ventricle. These are known as biventricular devices and are veryeffective in cardiac resynchronization therapy (CRT) and treatingcongestive heart failure (CHF).

Referring once again to FIG. 2, one can see, for example, the bipolarlead wires 104 a and 104 b that could be routed, for example, to thedistal TIP and RING into the right ventricle. The bipolar lead wires 104c and 104 d could be routed to a distal TIP and RING in the rightatrium. There is also an RF telemetry pin antenna 116 which is notconnected to the IS-1 or DS-1 connector block. This acts as a short stubantenna for picking up telemetry signals that are transmitted from theoutside of the device 100.

It should also be obvious to those skilled in the art that all of thedescriptions herein are equally applicable to other types of AIMDs.These include implantable cardioverter defibrillators (ICDs),neurostimulators, including deep brain stimulators, spinal cordstimulators, cochlear implants, incontinence stimulators and the like,and drug pumps. The present invention is also applicable to a widevariety of minimally invasive AIMDs. For example, in certain hospitalcath lab procedures, one can insert an AIMD for temporary use such as anICD. Ventricular assist devices also can fall into this type ofcategory. This list is not meant to be limiting, but is only example ofthe applications of the novel technology currently described herein.

FIG. 3 is an enlarged, fragmented cross-sectional view taken generallyalong line 3-3 of FIG. 2. Here one can see in cross-section the RFtelemetry pin 116 and the bipolar lead wires 104 a and 104 c which wouldbe routed to the cardiac chambers by connecting these lead wires to theinternal connectors 118 of the IS-1 header block 112 (FIG. 2). Theseconnectors are designed to receive the plug 110 which allows thephysicians to thread lead wires through the venous system down into theappropriate chambers of the heart 114. It will be obvious to thoseskilled in the art that tunneling of deep brain electrodes orneurostimulators are equivalent.

Referring back to FIG. 3, one can see a prior art feedthrough capacitor120 which has been bonded to the hermetic terminal assembly 106. Thesefeedthrough capacitors are well known in the art and are described andillustrated in U.S. Pat. Nos. 5,333,095, 5,751,539, 5,978,204,5,905,627, 5,959,829, 5,973,906, 5,978,204, 6,008,980, 6,159,560,6,275,369, 6,424,234, 6,456,481, 6,473,291, 6,529,103, 6,566,978,6,567,259, 6,643,903, 6,675,779, 6,765,780 and 6,882,248. In this case,a rectangular quadpolar feedthrough capacitor 120 is illustrated whichhas an external metallized termination surface 122. It includes embeddedelectrode plate sets 124 and 126. Electrode plate set 124 is known asthe ground electrode plate set and is terminated at the outside of thecapacitor 120 at the termination surface 122. These ground electrodeplates 124 are electrically and mechanically connected to the ferrule108 of the hermetic terminal assembly 106 using a thermosettingconductive polyimide or equivalent material 128 (equivalent materialswill include solders, brazes, conductive epoxies and the like). In turn,the hermetic seal terminal assembly 106 is designed to have its titaniumferrule 108 laser welded 130 to the overall housing 102 of the AIMD 100.This forms a continuous hermetic seal thereby preventing body fluidsfrom penetrating into and causing damage to the electronics of the AIMD.

It is also essential that the lead wires 104 and insulator 136 behermetically sealed, such as by the gold brazes or glass seals 132 and134. The gold braze 132 wets from the titanium ferrule 108 to thealumina ceramic insulator 136. In turn, the ceramic alumina insulator136 is also gold brazed at 134 to each of the lead wires 104. The RFtelemetry pin 116 is also gold brazed at 138 to the alumina ceramicinsulator 136. It will be obvious to those skilled in the art that thereare a variety of other ways of making such a hermetic terminal. Thiswould include glass sealing the leads into the ferrule directly withoutthe need for the gold brazes.

As shown in FIG. 3, the RF telemetry pin 116 has not been included inthe area of the feedthrough capacitor 120. The reason for this is thefeedthrough capacitor 120 is a very broadband single element EMI filterwhich would eliminate the desirable telemetry frequency.

FIG. 4 is a bottom view taken generally along line 4-4 in FIG. 3. Onecan see the gold braze 132 which completely seals the hermetic terminalinsulator 136 into the overall titanium ferrule 108. One can also seethe overlap of the capacitor attachment materials, shown as athermosetting conductive adhesive 128, which makes contact to the goldbraze 132 that forms the hermetic terminal 106.

FIG. 5 is an isometric view of the feedthrough capacitor 120. As one cansee, the termination surface 122 connects to the capacitor's internalground plate set 124. This is best seen in FIG. 6 where ground plate set124, which is typically silk-screened onto ceramic layers, is broughtout and exposed to the termination surface 122. The capacitor's four(quadpolar) active electrode plate sets 126 are illustrated in FIG. 7.In FIG. 6 one can see that the lead wires 104 are in non-electricalcommunication with the ground electrode plate set 124. However, in FIG.7 one can see that each one of the lead wires 104 is in electricalcontact with its corresponding active electrode plate set 126. Theamount of capacitance is determined by the overlap of the activeelectrode plate area 126 over the ground electrode plate area. One canincrease the amount of capacitance by increasing the area of the activeelectrode plate set 126. One can also increase the capacitance by addingadditional layers. In this particular application, we are only showingsix electrode layers: three ground plates 124 and three active electrodeplate sets 126 (FIG. 3). However, 10, 60 or even more than 100 such setscan be placed in parallel thereby greatly increasing the capacitancevalue. The capacitance value is also related to the dielectric thicknessor spacing between the ground electrode set 124 and the active electrodeset 126. Reducing the dielectric thickness increases the capacitancesignificantly while at the same time reducing its voltage rating. Thisgives the designer many degrees of freedom in selecting the capacitancevalue.

In the following description, functionally equivalent elements shown invarious embodiments will often be referred to utilizing the samereference number.

FIG. 8 is a general diagram of a unipolar active implantable medicaldevice system 100. The housing 102 of the active implantable medicaldevice 100 is typically titanium, ceramic, stainless steel or the like.Inside of the device housing are the AIMD electronic circuits. UsuallyAIMDs include a battery, but that is not always the case. For example,for a Bion, it can receive its energy from an external pulsing magneticfield. A lead wire 104 is routed from the AIMD 100 to a point 140 whereit is embedded in or affixed to body tissue. In the case of a spinalcord stimulator 100H, the distal TIP 140 could be in the spinal cord. Inthe case of a deep brain stimulator 100B, the distal electrode 140 wouldbe placed deep into the brain, etc. In the case of a cardiac pacemaker100C, the distal electrode 140 would typically be placed in the cardiacright ventricle.

FIG. 9 is very similar to FIG. 8 except that it is a bipolar system. Inthis case, the electric circuit return path is between the two distalelectrodes 140 and 140′. In the case of a cardiac pacemaker 100C, thiswould be known as a bipolar lead wire system with one of the electrodesknown as the distal TIP 142 and the other electrode which would float inthe blood pool known as the RING 144 (see FIG. 10). In contrast, theelectrical return path in FIG. 8 is between the distal electrode 140through body tissue to the conductive housing 102 of the implantablemedical device 100.

FIG. 10 illustrates a bipolar lead wire system with a distal TIP 142 andRING 144 typically as used in a cardiac pacemaker 100C. In all of theseapplications, the patient could be exposed to the fields of an MRIscanner or other powerful emitter used during a medical diagnosticprocedure. Currents that are directly induced in the lead wire system104 can cause heating by I²R losses in the lead wire system or byheating caused by current flowing in body tissue. If these currentsbecome excessive, the associated heating can cause damage or evendestructive ablation to body tissue.

The distal TIP 142 is designed to be implanted into or affixed to theactual myocardial tissue of the heart. The RING 144 is designed to floatin the blood pool. Because the blood is flowing and is thermallyconductive, the RING 144 structure is substantially cooled. In theory,however, if the lead curves, the RING 144 could also touch and becomeencapsulated by body tissue. The distal TIP 142, on the other hand, isalways thermally insulated by surrounding body tissue and can readilyheat up due to the RF pulse currents of an MRI field.

FIG. 11 is a schematic diagram showing a parallel combination of aninductor L and a capacitor C to be placed in the implantable lead wiresystems 104 previously described. This combination forms a parallel tankcircuit or band stop filter 146 which will resonate at a particularfrequency (f_(r)).

FIG. 12 gives the frequency of resonance equation f_(r) for the paralleltank circuit 146 of FIG. 11: where f_(r) is the frequency of resonancein hertz, L is the inductance in henries and C is the capacitance infarads. MRI systems vary in static field strength from 0.5 Tesla all theway up to 3 Tesla with newer research machines going much higher. Thisis the force of the main static magnetic field. The frequency of thepulsed RF field associated with MRI is found by multiplying the staticfield in Teslas times 42.45. Accordingly, a 3 Tesla MRI system has apulsed RF field of approximately 128 MHz.

Referring once again to FIG. 11, one can see that if the values of theinductor and the capacitor are selected properly, one could obtain aparallel tank resonant frequency of 128 MHz. For a 1.5 Tesla MRI system,the RF pulse frequency is 64 MHz. Referring to FIG. 12, one can see thecalculations assuming that the inductor value L is equal to onenanohenry. The one nanohenry comes from the fact that given the smallgeometries involved inside of the human body, a very large inductor willnot be possible. This is in addition to the fact that the use of ferritematerials or iron cores for such an inductor are not practical for tworeasons: 1) the static magnetic field from the MRI scanner would alignthe magnetic dipoles (saturate) in such a ferrite and therefore make theinductor ineffective; and 2) the presence of ferrite materials willcause severe MRI image artifacts. What this means is that if one wereimaging the right ventricle of the heart, for example, a fairly largearea of the image would be blacked out or image distorted due to thepresence of these ferrite materials and the way it interacts with theMRI field. It is also important that the inductance value not vary whilein the presence of the main static field.

The relationship between the parallel inductor L and capacitor C is alsovery important. One could use, for example, a very large value ofinductance which would result in a very small value of capacitance to beresonant, for example, at the MRI frequency of 64 MHz. However, using avery high value of inductor results in a high number of turns of verysmall wire. Using a high number of turns of very small diameter wire iscontraindicated for two reasons. The first reason is that the longlength of relatively small diameter wire results in a very high DCresistance for the inductor. This resistance is very undesirable becauselow frequency pacing or neurostimulator pulses would lose energy passingthrough the relatively high series resistance. This is also undesirablewhere the AIMD is sensing biologic signals. For example, in the case ofa pacemaker or deep brain stimulator, continuous sensing of lowfrequency biological signals is required. Too much series resistance ina lead wire system will attenuate such signals thereby making the AIMDless efficient. Accordingly, it is a preferred feature of the presentinvention that a relatively large value of capacitance will be used inparallel with a relatively small value of inductance, for example,employing highly volumetrically efficient ceramic dielectric capacitorsthat can create a great deal of capacitance in a very small space.

It should be also noted that below resonance, particularly at very lowfrequencies, the current in the parallel L-C band width stop filterpasses through the inductor element. Accordingly, it is important thatthe parasitic resistance of the inductor element be quite low.Conversely, at very low frequencies, no current passes through thecapacitor element. At high frequencies, the reactance of the capacitorelement drops to a very low value. However, as there is no case where itis actually desirable to have high frequencies pass through the tankfilter, the parasitic resistive loss of the capacitor is notparticularly important. This is also known as the capacitor's equivalentseries resistance (ESR). A component of capacitor ESR is the dissipationfactor of the capacitor (a low frequency phenomena). Off of resonance,it is not particularly important how high the capacitor's dissipationfactor or overall ESR is when used as a component of a parallel tankcircuit 146 as described herein. Accordingly, an air wound inductor isthe ideal choice because it is not affected by MRI signals or fields.Because of the space limitations, however, the inductor will not be veryvolumetrically efficient. For this reason, it is preferable to keep theinductance value relatively low (in the order of 1 to 100 nanohenries).

Referring once again to FIG. 12, one can see the calculations forcapacitance by algebraically solving the resonant frequency f_(r)equation shown for C. Assuming an inductance value of one nanohenry, onecan see that 6 nano-farads of capacitance would be required. Sixnano-farads of capacitance is a relatively high value of capacitance.However, ceramic dielectrics that provide a very high dielectricconstant are well known in the art and are very volumetricallyefficient. They can also be made of biocompatible materials making theman ideal choice for use in the present invention.

FIG. 13 is a graph showing impedance versus frequency for the paralleltank, band stop filter circuit 146 of FIG. 11. As one can see, usingideal circuit components, the impedance measured between points A and Bfor the parallel tank circuit 146 shown in FIG. 11 is very low (zero)until one approaches the resonant frequency f_(r). At the frequency ofresonance, these ideal components combine together to look like a veryhigh or, ideally, an infinite impedance. The reason for this comes fromthe denominator of the equation Z_(ab) for the impedance for theinductor in parallel with the capacitor shown as FIG. 14. When theinductive reactance is equal to the capacitive reactance, the twoimaginary vectors cancel each other and go to zero. Referring to theequations in FIGS. 14 and 15, one can see in the impedance equation forZ_(ab), that a zero will appear in the denominator when X_(L)=X_(C).This has the effect of making the impedance approach infinity as thedenominator approaches zero. As a practical matter, one does not reallyachieve an infinite impedance. However, tests have shown that severalhundred ohms can be realized which offers a great deal of attenuationand protection to RF pulsed currents from MRI. What this means is thatat one particular unique frequency, the impedance between points A and Bin FIG. 11 will appear very high (analogous to opening a switch).Accordingly, it would be possible, for example, in the case of a cardiacpacemaker, to design the cardiac pacemaker for compatibility with onesingle popular MRI system. For example, in the AIMD patient literatureand physician manual it could be noted that the pacemaker lead wiresystem has been designed to be compatible with 3 Tesla MRI systems.Accordingly, with this particular device, a distal TIP band stop filter146 would be incorporated where the L and the C values have beencarefully selected to be resonant at 128 MHz, presenting a high oralmost infinite impedance at the MRI pulse frequency.

FIG. 16 is a schematic drawing of the parallel tank circuit 146 of FIG.11, except in this case the inductor L and the capacitor C are notideal. That is, the capacitor C has its own internal resistance R_(C),which is otherwise known in the industry as dissipation factor orequivalent series resistance (ESR). The inductor L also has a resistanceR_(L). For those that are experienced in passive components, one wouldrealize that the inductor L would also have some parallel capacitance.This parasitic capacitance comes from the capacitance associated withadjacent turns. However, the inductance value contemplated is so lowthat one can assume that at MRI pulse frequencies, the inductor'sparallel capacitance is negligible. One could also state that thecapacitor C also has some internal inductance which would appear inseries. However, the novel capacitors described below are very small orcoaxial and have negligible series inductance. Accordingly, the circuitshown in FIG. 16 is a very good approximation model for the novelparallel tank circuits 146 as described herein.

This is best understood by looking at the FIG. 16 circuit 146 at thefrequency extremes. At very low frequency, the inductor reactanceequation is X_(L)=2πfL (reference FIG. 15). When the frequency f isclose to zero (DC), this means that the inductor looks like a shortcircuit. It is generally the case that biologic signals are lowfrequency, typically between 10 Hz and 1000 Hz. For example, in acardiac pacemaker 100C, all of the frequencies of interest appearbetween 10 Hz and 1000 Hz. At these low frequencies, the inductivereactance X_(L) will be very close to zero ohms. Over this range, on theother hand, the capacitive reactance X_(C) which has the equationX_(C)=1/(2πfc) will look like an infinite or open circuit (referenceFIG. 15). As such, at low frequencies, the impedance between points Aand B in FIG. 16 will equal to R_(L). Accordingly, the resistance of theinductor (R_(L)) should be kept as small as possible to minimizeattenuation of biologic signals or attenuation of stimulation pulses tobody tissues. This will allow biologic signals to pass through the bandstop filter 146 freely. It also indicates that the amount of capacitiveloss R_(C) is not particularly important. As a matter of fact, it wouldbe desirable if that loss were fairly high so as to not freely pass veryhigh frequency signals (such as undesirable EMI from cellular phones).It is also desirable to have the Q of the circuit shown in FIG. 16relatively low so that the band stop frequency bandwidth can be a littlewider. In other words, in a preferred embodiment, it would be possibleto have a band stop wide enough to block both 64 MHz and 128 MHzfrequencies thereby making the medical device compatible for use in both1.5 Tesla and 3 Tesla MRI systems.

FIG. 17 is a drawing of the unipolar AIMD lead wire system, previouslyshown in FIG. 8, with the band stop filter 146 of the present inventionadded near the distal electrode 140. As previously described, thepresence of the tank circuit 146 will present a very high impedance atone or more specific MRI RF pulse frequencies. This will preventcurrents from circulating through the distal electrode 140 into bodytissue at this selected frequency(s). This will provide a very highdegree of important protection to the patient so that overheating doesnot cause tissue damage.

FIG. 18 is a representation of the novel band stop tank filter 146 usingswitches that open and close at various frequencies to illustrate itsfunction. Inductor L has been replaced with a switch S_(L). When theimpedance of the inductor is quite low, the switch S_(L) will be closed.When the impedance or inductive reactance of the inductor is high, theswitch S_(L) will be shown open. There is a corresponding analogy forthe capacitor element C. When the capacitive reactance looks like a verylow impedance, the capacitor switch S_(C) will be shown closed. When thecapacitive reactance is shown as a very high impedance, the switch S_(C)will be shown open. This analogy is best understood by referring toFIGS. 19, 20 and 21.

FIG. 19 is the low frequency model of the band stop filter 146. At lowfrequencies, capacitors tend to look like open circuits and inductorstend to look like short circuits. Accordingly, switch S_(L) is closedand switch S_(C) is open. This is an indication that at frequenciesbelow the resonant frequency of the band stop filter 146 that currentswill flow only through the inductor element and its correspondingresistance R_(L). This is an important consideration for the presentinvention that low frequency biological signals not be attenuated. Forexample, in a cardiac pacemaker, frequencies of interest generally fallbetween 10 Hz and 1000 Hz. Pacemaker pacing pulses fall within thisgeneral frequency range. In addition, the implantable medical device isalso sensing biological frequencies in the same frequency range.Accordingly, such signals must be able to flow readily through the bandstop filter's inductor element. A great deal of attention should be paidto the inductor design so that it has a very high quality factor (Q) anda very low value of parasitic series resistance R_(L).

FIG. 20 is a model of the novel band stop filter 146 at its resonantfrequency. By definition, when a parallel tank circuit is at resonance,it presents a very high impedance to the overall circuit. Accordingly,both switches S_(L) and S_(C) are shown open. For example, this is howthe band stop filter 146 prevents the flow of MRI currents throughpacemaker lead wires and/or into body tissue at a selected MRI RF pulsedfrequency.

FIG. 21 is a model of the band stop filter 146 at high frequency. Athigh frequencies, inductors tend to look like open circuits.Accordingly, switch S_(L) is shown open. At high frequencies, idealcapacitors tend to look like short circuits, hence switch S_(C) isclosed. It should be noted that real capacitors are not ideal and tendto degrade in performance at high frequency. This is due to thecapacitor's equivalent series inductance and equivalent seriesresistance. Fortunately, for the present invention, it is not importanthow lossy (resistive) the capacitor element C gets at high frequency.This will only serve to attenuate unwanted electromagnetic interferencefrom flowing in the lead wire system. Accordingly, in terms ofbiological signals, the equivalent series resistance R_(C) and resultingquality factor of the capacitor element C is not nearly as important asthe quality factor of the inductor element L. The equation for inductivereactance (X_(L)) is given in FIG. 15. The capacitor reactance equation(X_(C)) is also given in FIG. 15. As one can see, when one inserts zeroor infinity for the frequency, one derives the fact that at very lowfrequencies inductors tend to look like short circuits and capacitorstend to look like open circuits. By inserting a very high frequency intothe same equations, one can see that at very high frequency idealinductors look like an infinite or open impedance and ideal capacitorslook like a very low or short circuit impedance.

FIG. 22 is a decision tree block diagram that better illustrates thedesign process herein. Block 148 is an initial decision step thedesigner must make. For illustrative purposes, we will start with avalue of capacitance that is convenient. This value of capacitance isgenerally going to relate to the amount of space available in the AIMDlead wire system and other factors. These values for practical purposesgenerally range in capacitance value from a few tens of picofarads up toabout 10,000 picofarads. This puts practical boundaries on the amount ofcapacitance that can be effectively packaged within the scope of thepresent invention. However, that is not intended to limit the generalprinciples of the present invention, but just describe a preferredembodiment. Accordingly, in the preferred embodiment, one will selectcapacitance values generally ranging from 100 picofarads up to about4000 picofarads and then solve for a corresponding inductance valuerequired to be self-resonant at the selected telemetry frequency.Referring back to FIG. 22, one makes the decision whether the design wasC first or L first. If one makes a decision to assume a capacitancevalue C first then one is directed to the left to block 150. In block150, one does an assessment of the overall packaging requirements of adistal TIP 142 band stop filter 146 and then assumes a realizablecapacitance value. So, in decision block 150, we assume a capacitorvalue. We then solve the resonant tank equation f_(r) from FIG. 12 atblock 152 for the required value of inductance (L). We then look at anumber of inductor designs to see if the inductance value is realizablewithin the space, parasitic resistance R_(C), and other constraints ofthe design. If the inductance value is realizable, then we go on toblock 154 and finalize the design. If the inductance value is notrealizable within the physical and practical constraints, then we needto go back to block 150 and assume a new value of capacitance. One maygo around this loop a number of times until one finally comes up with acompatible capacitor and an inductor design. In some cases, one will notbe able to achieve a final design using this alone. In other words, onemay have to use a custom capacitor value or design in order to achieve aresult that meets all of the design criteria. That is, a capacitordesign with high enough internal losses R_(C) and an inductor designwith low internal loss R_(L) such that the band stop filter 146 has therequired quality factor (Q), that it be small enough in size, that ithave sufficient current and high voltage handling capabilities and thelike. In other words, one has to consider all of the design criteria ingoing through this decision tree.

In the case where one has gone through the left hand decision treeconsisting of blocks 150, 152 and 154 a number of times and keeps comingup with a “no,” then one has to assume a realizable value of inductanceand go to the right hand decision tree starting at block 156. One thenassumes a realizable value of inductance (L) with a low enough seriesresistance for the inductor R_(L) such that it will work and fit intothe design space and guidelines. After one assumes that value ofinductance, one then goes to decision block 158 and solves the equationC in FIG. 12 for the required amount of capacitance. After one finds thedesired amount of capacitance C, one then determines whether that customvalue of capacitance will fit into the design parameters. If thecapacitance value that is determined in step 160 is realizable, then onegoes on and finalizes the design. However, if it is not realizable, thenone can go back up to step 156, assume a different value of L and gothrough the decision tree again. This is done over and over until onefinds combinations of L and C that are practical for the overall design.

For purposes of the present invention, it is possible to use seriesdiscrete inductors or parallel discrete capacitors to achieve the sameoverall result. For example, in the case of the inductor element L, itwould be possible to use two, three or even more (n) individual inductorelements in series. The same is true for the capacitor element thatappears in the parallel tank filter 146. By adding or subtractingcapacitors in parallel, we are also able to adjust the total capacitancethat ends up resonating in parallel with the inductance.

It is also possible to use a single inductive component that hassignificant parasitic capacitance between its adjacent turns. A carefuldesigner using multiple turns could create enough parasitic capacitancesuch that the coil becomes self-resonant at a predetermined frequency.In this case, the predetermined frequency would be the MRI pulsedfrequency.

Efficiency of the overall tank circuit 146 is also measured in terms ofa quality factor, Q, although this factor is defined differently thanthe one previously mentioned for discrete capacitors and inductors. Thecircuit Q is typically expressed using the following equation:

$Q = \frac{f_{r}}{\Delta\; f_{3\;{dB}}}$

Where f_(r) is the resonance frequency, and Δf_(3 dB) shown as points aand b in FIG. 23, is the bandwidth of the band stop filter 146.Bandwidth is typically taken as the difference between the two measuredfrequencies, f₁ and f₂, at the 3 dB loss points as measured on aninsertion loss chart, and the resonance frequency is the average betweenf₁ and f₂. As can be seen in this relationship, higher Q values resultin a narrower 3 dB bandwidth.

Material and application parameters must be taken into considerationwhen designing tank filters. Most capacitor dielectric materials age1%-5% in capacitance values per decade of time elapsed, which can resultin a shift of the resonance frequency of upwards of 2.5%. In a high-Qfilter, this could result in a significant and detrimental drop in theband stop filter performance. A lower-Q filter would minimize theeffects of resonance shift and would allow a wider frequency bandthrough the filter. However, very low Q filters display lower thandesirable attenuation behavior at the desired band stop frequency (seeFIG. 23, curve 162). For this reason, the optimum Q for the band stopfilter of the present invention will embody a high Q inductor L and arelatively low Q capacitor C which will result in a medium Q tank filteras shown in curve 164 of FIG. 23.

Accordingly, the “Q” or quality factor of the tank circuit is veryimportant. As mentioned, it is desirable to have a very low loss circuitat low frequencies such that the biological signals not be undesirablyattenuated. The quality factor not only determines the loss of thefilter, but also affects its 3 dB bandwidth. If one does a plot of thefilter response curve (Bode plot), the 3 dB bandwidth determines howsharply the filter will rise and fall. With reference to curve 166 ofFIG. 23, for a tank that is resonant at 128 MHz, an ideal response wouldbe one that had infinite attenuation at 128 MHz, but had zeroattenuation at low frequencies below 1 KHz. Obviously, this is notpossible given the space limitations and the realities of the parasiticlosses within components. In other words, it is not possible (other thanat cryogenic temperatures) to build an inductor that has zero internalresistance. On the other hand, it is not possible to build a perfect(ideal) capacitor either. Capacitors have internal resistance known asequivalent series resistance and also have small amounts of inductance.Accordingly, the practical realization of a circuit, to accomplish thepurposes of the present invention, is a challenging one.

The performance of the circuit is directly related to the efficiency ofboth the inductor and the capacitor; the less efficient each componentis, the more heat loss that results, and this can be expressed by theaddition of resistor elements to the ideal circuit diagram. The effectof lower Q in the tank circuit is to broaden the resonance peak aboutthe resonance frequency. By deliberately using a low Q capacitor, onecan broaden the resonance such that a high impedance (high attenuation)is presented at multiple MRI RF frequencies, for example 64 MHz and 128MHz.

Referring again to FIG. 23, one can see curve 164 wherein a lowresistive loss high Q inductor has been used in combination with arelatively high ESR low Q capacitor. This has a very desirable effect inthat at very low frequencies, the impedance of the tank circuit 146 isessentially zero ohms (or zero dB loss). This means that biologicfrequencies are not undesirably attenuated. However, one can see thatthe 3 db bandwidth is much larger. This is desirable as it will blockmultiple RF frequencies. As one goes even higher in frequency, curve 164will desirably attenuate other high frequency EMI signals, such as thosefrom cellular telephones, microwave ovens and the like. Accordingly, itis often desirable that very low loss inductors be used in combinationwith relatively high loss (and/or high inductance) capacitors to achievea medium or lower Q band stop filter. Again referring to FIG. 23, onecan see that if the Q of the overall circuit or of the individualcomponents becomes too low, then we have a serious degradation in theoverall attenuation of the band stop filter at the MRI pulsefrequencies. Accordingly, a careful balance between component design andtank circuit Q must be achieved.

Referring once again to FIG. 17, one can also increase the value ofR_(C) by adding a separate discrete component in series with thecapacitor element. For example, one could install a small capacitor chipthat had a very low equivalent series resistance and place it in serieswith a resistor chip. This would be done to deliberately raise the valueof R_(C) in the circuit as shown in FIG. 17. By carefully adjusting thisvalue of R_(C), one could then achieve the ideal curve 164 as shown inFIG. 23.

FIG. 24 is a tracing of an actual patient X-ray. This particular patientrequired both a cardiac pacemaker 100C and an implantable cardioverterdefibrillator 1001. The corresponding implantable lead wire system 104,as one can see, makes for a very complicated antenna and loop couplingsituation. The reader is referred to the article entitled, “Estimationof Effective Lead Loop Area for Implantable Pulse Generator andImplantable Cardioverter Defibrillators” provided by the AAMI PacemakerEMC Task Force.

Referring again to FIG. 24, one can see that from the pacemaker 100C,there is an electrode in both the right atrium and in the rightventricle. Both these involve a TIP and RING electrode. In the industry,this is known as a dual chamber bipolar lead wire system. Accordingly,the band stop filters 146 of the present invention would need to beplaced at least in the distal TIP in the right atrium and the distal TIPin the right ventricle from the cardiac pacemaker. One can also see thatthe implantable cardioverter defibrillator (ICD) 1001 is implanteddirectly into the right ventricle. Its shocking TIP and perhaps itssuper vena cava (SVC) shock coil would also require a band stop filtersof the present invention so that MRI exposure cannot induce excessivecurrents into the associated lead wire system (S). Modern implantablecardioverter defibrillators (ICDs) incorporate both pacing andcardioverting (shock) features. Accordingly, it is becoming quite rarefor a patient to have a lead wire layout as shown in the X-ray of FIG.24. However, the number of electrodes remain the same. There are alsonewer combined pacemaker/ICD systems which include biventricularpacemaking (pacing of the left ventricle). These systems can have asmany as 9 to even 12 lead wires.

FIG. 25 is a line drawing of an actual patient cardiac X-ray of one ofthe newer bi-ventricular lead wire systems with various types ofelectrode TIPS shown. The new bi-ventricular systems are being used totreat congestive heart failure, and make it possible to implant leadsoutside of the left ventricle. This makes for a very efficient pacingsystem; however, the implantable lead wire system 104 is quite complex.When a lead wire system 104, such as those described in FIGS. 8, 9, 10and 11, are exposed to a time varying electromagnetic field, electriccurrents can be induced into such lead wire systems. For thebi-ventricular system, band stop filters 146 would be required at eachof the three distal TIPs and optionally at RING and SVC locations.

FIG. 26 illustrates a single chamber bipolar cardiac pacemaker lead wireshowing the distal TIP 142 and the distal RING 144 electrodes. This is aspiral wound system where the RING coil 104 is wrapped around the TIPcoil 104′. There are other types of pacemaker lead wire systems in whichthese two leads lay parallel to one another (known as a bifilar leadsystem).

FIG. 27 is a schematic illustration of the area 27-27 in FIG. 26. In thearea of the distal TIP 142 and RING 144 electrodes, band stop filters146 and 146′ have been placed in series with each of the respective TIPand RING circuits. Accordingly, at MRI pulsed frequencies, an opencircuit will be presented thereby stopping the flow of undesirable RFcurrent.

Although several embodiments of the invention have been described indetail, for purposes of illustration, various modifications of each maybe made without departing from the spirit and scope of the invention.Accordingly, the invention is not to be limited, except as by theappended claims.

1. A band stop filter for an implantable lead wire of an activeimplantable medical device, which comprises: a) a lead wire having alength extending between and to a proximal end and a distal end; and b)at least one band stop filter comprising a capacitor in parallel with aninductor, said parallel capacitor and inductor combination placed inseries with the lead wire somewhere along the length between and to theproximal end and the distal end of the lead wire wherein values ofcapacitance and inductance have been selected such that the band stopfilter is resonant at a selected frequency and further wherein theoverall Q of the band stop filter is selected to balance impedance atthe selected frequency versus frequency band width characteristics. 2.The band stop filter of claim 1, wherein the Q of the inductor isrelatively high and the Q of the capacitor is relatively low to selectthe overall Q of the band stop filter.
 3. The band stop filter of claim2, wherein the inductor has a relatively low resistive loss; and whereinthe capacitor has a relatively high equivalent series resistance.
 4. Theband stop filter of claim 3, wherein the overall Q of the band stopfilter is selected to attenuate current flow through the lead wire alonga range of selected frequencies.
 5. The band stop filter of claim 4,wherein the range of selected frequencies includes a plurality of MRIpulsed frequencies.
 6. The band stop filter of claim 1, wherein the bandstop filter is disposed adjacent to a distal tip of the lead wire. 7.The band stop filter of claim 6, wherein the band stop filter isintegrated into a selected one of a TIP electrode and a RING electrode.8. A band stop filter for a medical diagnostic or therapeutic devicecomprising an active implantable medical device and an implantable leadwire having a length extending therefrom between and to a proximal endand a distal end and adapted to be in contact with biological cells, theband stop filter comprising: at least one a band stop filter associatedwith the lead wire, for attenuating current flow through the lead wireat a selected frequency, wherein the band stop filter comprises acapacitor in parallel with an inductor, said parallel capacitor andinductor placed in series with the lead wire somewhere along the lengthbetween and to the proximal end and the distal end of the lead wire,wherein values of capacitance and inductance are selected such that theband stop filter is resonant at the selected frequency.
 9. The band stopfilter of claim 8, wherein the Q of the inductor is relatively high andthe Q of the capacitor is relatively low to select the overall Q of theband stop filter.
 10. The band stop filter of claim 9, wherein theinductor has a relatively low resistive loss.
 11. The band stop filterof claim 9, wherein the capacitor has a relatively high equivalentseries resistance.
 12. The band stop filter of claim 9, wherein theoverall Q of the band stop filter is selected to attenuate current flowthrough the lead wire along a range of selected frequencies.
 13. Theband stop filter of claim 12, wherein the range of selected frequenciesincludes a plurality of MRI pulsed frequencies.
 14. The band stop filterof claim 8, wherein the band stop filter is disposed adjacent to thedistal tip of the implantable lead wire.
 15. The band stop filter ofclaim 14, wherein the band stop filter is integrated into a selected oneof a TIP electrode and a RING electrode.
 16. The band stop filter ofclaim 15, wherein the overall Q of the band stop filter is selected toattenuate current flow through the implantable lead wire along a rangeof selected frequencies.
 17. The band stop filter of claim 8, whereinthe active implantable medical device, comprises cochlear implants,piezoelectric sound bridge transducers, neurostimulators, brainstimulators, cardiac pacemakers, ventricular assist devices, artificialhearts, drug pumps, bone growth stimulators, bone fusion stimulators,urinary incontinence devices, pain relief spinal cord stimulators,anti-tremor stimulators, gastric stimulators, implantable cardioverterdefibrillators, pH probes, congestive heart failure devices,neuromodulators, cardiovascular stents, and orthopedic implants.
 18. Theband stop filter of claim 8, wherein the overall Q of the band stopfilter is selected to balance impedance at the selected frequency versusfrequency band width characteristics.